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OBJECTIVES: Determine the outcomes of polytetrafluoroethylene (PTFE) covered stents for coronary artery perforation (CAP) and coronary artery aneurysm (CAA). BACKGROUND: PTFE covered stents have been used for treatment of potentially life-threatening CAP and CAA. The short and long-term outcomes of the PTFE covered stent for CAP and CAA have not been well studied. METHODS: We performed a retrospective study of PTFE covered stents that were placed in the patients from 2003 to 2017. Short term outcomes included in-hospital mortality, pericardial effusion, cardiac tamponade, and length of stay. Long-term outcomes included target lesion revascularization (TLR), in-stent restenosis (ISR), and long-term mortality. RESULTS: Fifty-three PTFE covered stents were placed in 32 patients of which there were 24 patients with a CAP with a mean age of 75 ± 8 years. Two patients died in-hospital, with no additional deaths at 30 days. The rate of ISR was 25%, with estimated rates of TLR of 2.6% (3 years) and 17.8% (5 years). The median survival was 55.6 months, with survival at 10 years estimated to be 30.9%. Eight patients received a PTFE covered stent for CAA with a mean age of 59 ± 15 years with no in-hospital or 30-day mortality. Median follow-up of 49 months showed no evidence of TLR. The all-cause mortality was 12% at 1 year and 38% at 3 years. CONCLUSIONS: PTFE covered stents is an effective option in patients with CAP and CAA. The long-term outcomes may be related to the pathology of the disease rather than the stent itself.

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OBJECTIVES: Multisite procedure-based randomized trials may be confounded by performance variability and variability among sites. Therefore, we studied variability in mortality and stroke after patients were randomized to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial. METHODS: Patients at intermediate risk for SAVR were randomized to SAVR (n = 1017) or TAVR (n = 1011) with a SAPIEN XT device (Edwards Lifesciences, Irvine, Calif) at 54 sites. Patients were followed to 2 years. A mixed-effect model quantified variability at intersite and intrasite levels. RESULTS: There were 336 deaths (SAVR 170, TAVR 166) and 176 strokes (SAVR 85, TAVR 91). Intersite variability for mortality was similar across sites for SAVR (hazard ratios ranging from 0.52-1.93 among sites) and TAVR (hazard ratios ranging from 0.49-2.03), but intersite variability for stroke was greater for SAVR (hazard ratios ranging from 0.44-2.26) than for TAVR (no detectable variability). Case mix and lower site trial volume accounted for 37% of mortality intersite variability for SAVR and 73% for TAVR, but only 14% for stroke for SAVR. Intrasite mortality hazard ratios demonstrated all but 1 site's 95% confidence interval overlapped 1.0, indicating generally similar SAVR and TAVR mortalities within sites. CONCLUSIONS: Intersite variability was similar for mortality in SAVR and TAVR, but variability for stroke was greater for SAVR than for TAVR. Intrasite events were similar for both SAVR and TAVR. These findings suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results.

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BACKGROUND: In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes. OBJECTIVES: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD. METHODS: Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes. RESULTS: Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p

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Importance: Reducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR). Objective: This study evaluated the trends of stroke occurring within 30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk. Design, Setting, and Participants: Retrospective cohort study including 101â¯430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017. Exposures: TAVR. Main Outcomes and Measures: The rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively. Results: Among 101â¯430 patients included in the study (median age, 83 years [interquartile range {IQR}, 76-87 years]; 47â¯797 women [47.1%]; and 85â¯147 patients [83.9%] treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99â¯140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio [HR], 6.1 [95% CI, 5.4-6.8]; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83). Conclusions and Relevance: Between 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.

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Importance: Although several studies have reported data on surgical aortic valve durability, variability in study methodologies and definitions as well as inadequate follow-up make the interpretation of data from these studies difficult to interpret. Objective: To review available data on structural valve deterioration (SVD) of surgical bioprosthetic aortic valves by examining the published literature as well as data reported to the US Food and Drug Administration (FDA). Evidence Review: A systematic review using Preferred Reporting Items for Systematic Review and Meta-Analysis reporting guidelines to obtain all available data from preexisting literature on the actuarial freedom from SVD and outcomes of SVD. Data were collected from database inception to November 2016. Additionally, data reported to the FDA were obtained. Findings: In total, 167 studies and 12 FDA reports including 101â¯650 patients and 17 different valve types were analyzed. There were 11 different definitions of SVD used in the studies. Core laboratory data were available for 11 studies. Mean follow-up ranged from less than 1 year to 14 years. Kaplan-Meier estimates were reported for up to 30 years of follow-up, with 0% to 37% of patients remaining at risk at maximum follow-up. Food and Drug Administration-reported data are similarly variable in duration (mean follow-up range, 1.2 to 7 years) and completeness of follow-up, with final follow-up of 0.1% to 95%. Conclusions and Relevance: There is considerable variability in reporting SVD of surgical aortic valves, with different definitions and inadequate long-term systematically collected core laboratory data. Rigorously collected long-term data with standardized definitions for surgical valves are needed to provide a benchmark for the durability of rapidly evolving transcatheter valves.

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BACKGROUND: Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain. OBJECTIVES: The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR. METHODS: The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (≤7 days) and late (7 days to 48 months) post-procedure; and 3) association between stroke and quality of life 1 year post-procedure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score. RESULTS: Thirty-day stroke (5.1% vs. 3.7%; p = 0.09) was similar, but 30-day major stroke (3.9% vs. 2.2%; p = 0.018) was lower after TF-TAVR than SAVR. In both groups, risk of stroke peaked in the first post-procedure day, followed by a near-constant low-level risk to 48 months. Major stroke was associated with a decline in quality of life at 1 year in both SAVR (KCCQ score median [15th, 85th percentile]: 79 [53, 94] without major stroke vs. 64 [30, 94] with major stroke; p = 0.03) and TF-TAVR (78 [49, 96] without major stroke vs. 60 [8, 99] with major stroke; p = 0.04). CONCLUSIONS: Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR. Periprocedural strategies are needed to reduce stroke risk after aortic valve procedures. (Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894).

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BACKGROUND: The Society of Thoracic Surgeons (STS) scores are used to screen patients for transcatheter aortic valve replacement (TAVR). The STS scores were also used to risk stratify patients in major TAVR trials. This study evaluates the reclassification of predicted risk of mortality by the currently available online STS score calculator compared with the 2008 STS risk model in patients undergoing TAVR. METHODS AND RESULTS: All patients who underwent TAVR from 2006 to 2016 were included in the study. The STS scores for all included patients were calculated by applying the 2008 STS risk model and again using the current STS online calculator. Among 1209 patients who underwent TAVR, 30-day mortality was 27 (2.2%). The overall predicted risk of mortality estimated by using the current online STS risk calculator was significantly lower than the 2008 STS risk model (6.3±4.4 vs 7.3±4.9; P<0.001). A total of 235 (19%) patients were reclassified into a lower risk category per the current STS risk model. In a multivariable logistic regression analysis, patients with persistent atrial fibrillation (odds ratio, 1.4; 95% CI, 1.0-1.9; P=0.03), chronic heart failure (odds ratio, 6.0; 95% CI, 3.8-10.1; P<0.001), and New York Heart Association class IV heart failure (odds ratio, 2.4; 95% CI, 1.3-4.4; P=0.007) were more likely to be reclassified into a lower risk category per the current STS risk model. CONCLUSIONS: The current STS calculation method produces significantly lower predicted risk of mortality than the 2008 calculator, more pronounced in patients with certain comorbid conditions. These results should be considered while evaluating data from prior studies of TAVR.

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OBJECTIVES: We investigated the hemodynamic durability of the transcatheter aortic valves (TAVs) using the updated Valve Academic Research Consortium-2 (VARC-2) criteria. BACKGROUND: The updated VARC-2 consensus criteria combine flow-dependent and flow-independent echocardiographic parameters for hemodynamic assessment of TAVR. Data on the hemodynamic durability of TAV and clinical risk factors associated with valve hemodynamic deterioration (VHD) are lacking. METHODS: All patients (n = 276) who received TAV between 2006 and 2012 and had ≥2 follow-up echocardiograms were studied. RESULTS: During a median follow up period of 3.3 (1.8-4.4) years, 8 patients (3%) developed moderate to severe valve stenosis per the VARC-2 criteria, while 20 had mild stenosis. In a Cox proportional hazards model analysis, moderate to severe stenosis by VARC-2 criteria was associated with younger age (P = 0.03, HR 0.94), absence of dual antiplatelet therapy (DAPT) (P = 0.026, HR 0.18), and lower baseline left ventricular ejection fraction (LVEF) (P = 0.006, HR 0.94). Longitudinal analysis using a mixed effect model showed that presence of stenosis by VARC-2 criteria was associated with an increase in aortic valve mean gradient (P < 0.001, +2.34 mmHg per year). In a subset of 93 patients with analyzable fluoroscopic images, deeper valve implantation was associated with increase in mean gradient (P = 0.004, +0.2 mmHg per year per 1 mm increase in implantation depth). CONCLUSION: Despite good hemodynamic durability of TAV, patients with younger age, lower LVEF and those not on DAPT after undergoing a TAV replacement, are at a higher risk for development of VHD.

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OBJECTIVES: The aim of this study was to study differences in progression of aortic stenosis (AS) in patients with mediastinal radiotherapy (XRT)-associated moderate AS versus a matched cohort during the same time frame, and to ascertain need for aortic valve replacement (AVR) and longer-term survival. BACKGROUND: Rate of progression of XRT-associated moderate AS and its impact on outcomes is not well-described. METHODS: We included 81 patients (age 61 ± 13 years; 57% female) with at least XRT-associated moderate AS (aortic valve area [AVA] 1.05 ± 0.3 cm2; mean gradient 24 ± 10 mm Hg) who had ≥2 transthoracic echocardiograms (TTEs) 1 year apart and matched them in a 1:2 fashion on the basis of age, sex, and AVA with those without prior XRT. Serial aortic valve gradients and AVA were recorded. AVR and longer-term all-cause mortality during follow-up were recorded. RESULTS: A total of 100% of patients had 1, a total of 71% had 2, and 39% had 3 follow-up TTEs. Before AVR, mean AVG and AVA were not significantly different between XRT and comparison groups. At 3.6 ± 2.0 years from baseline TTE, 146 (60%) underwent AVR (16% transcatheter), with significantly more patients in the XRT group undergoing AVR (80% vs. 50%; p < 0.01), at a much shorter time (2.9 ± 1.6 years vs. 4.1 ± 2.4 years; p < 0.01). At 6.6 ± 4.0 years from the initial TTE, 49 (20%) patients died, with a significantly higher mortality in the XRT group (40% vs. 11%; p < 0.01), with prior XRT associated with increased longer-term mortality, whereas AVR was associated with improved longer-term survival. CONCLUSIONS: In patients with moderate AS, those with prior XRT have a similar rate of progression of AS versus a comparison group. A higher proportion of patients in the XRT group were referred for AVR at a shorter time from baseline TTE. Despite that, the XRT patients had significantly higher longer-term mortality, and prior exposure to XRT was associated with significantly increased longer-term mortality.

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OBJECTIVES: The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR). BACKGROUND: In patients with severe aortic stenosis at intermediate surgical risk, TAVR using the SAPIEN XT valve (XT-TAVR) results in similar QoL compared with SAVR. Compared with SAPIEN XT, the SAPIEN 3 valve offers a lower delivery profile and modifications to reduce paravalvular regurgitation. METHODS: Between February and December 2014, 1,078 patients at intermediate surgical risk with severe aortic stenosis were treated with S3-TAVR in the PARTNER S3i (Placement of Aortic Transcatheter Valve) trial. QoL was assessed at baseline, 1 month, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short Form-36, and EQ-5D. QoL outcomes of S3-TAVR patients were compared with those in the SAVR and XT-TAVR arms of the PARTNER 2A trial using propensity score stratification to adjust for differences between the treatment groups. RESULTS: Over 1 year, S3-TAVR was associated with substantial improvements in QoL compared with baseline. At 1 month, S3-TAVR was associated with better QoL than either SAVR or XT-TAVR (adjusted differences in Kansas City Cardiomyopathy Questionnaire overall summary score 15.6 and 3.7 points, respectively; p < 0.001). At 1 year, the differences in QoL between S3-TAVR and both SAVR and XT-TAVR were reduced but remained statistically significant (adjusted differences 2.0 and 2.2 points, respectively; p < 0.05). Similar results were seen for generic QoL outcomes. CONCLUSIONS: Among patients at intermediate surgical risk with severe aortic stenosis, S3-TAVR resulted in improved QoL at both 1 month and 1 year compared with both XT-TAVR and SAVR.

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In year 2016, the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI) updated Recommendations for the assessment and grading of diastolic dysfunction (DD). We aimed to assess the applicability of this DD grading method and its association with prognosis in patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI). We retrospectively identified 237 consecutive patients with severe AS who underwent trans-femoral TAVI. Baseline transthoracic echocardiography was evaluated to assess pre- and post-TAVI diastolic function according to the current ASE/EACVI Recommendations. Prior to TAVI, 41 (17%) patients were diagnosed as having grade I DD, 111 (47%) patients had grade II DD, 80 (34%) had grade III DD. DD grade after TAVI decreased (p < 0.001) with 75 patients (32%) reclassified to a lower DD grade. During the median follow-up of 1,320 days, 136 (57%) patients died. In univariable Cox proportional hazards model analysis, neither pre- nor post-TAVI DD grade were associated with prognosis. However, patients with grade III DD detected before TAVI and AR≥ 2 after TAVI had poorer survival (p<0.008). Patients with grade III DD detected after TAVI and AR≥ 2 after TAVI had poorer prognosis (p = 0.002). TAVI improves DD grade. While poor DD grade was not associated with mortality after treatment of AS by TAVI, concomitant presence of DD and post-procedural AR carried a poor prognosis.

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